An effectiveness-implementation hybrid type 1 trial assessing the impact of group versus individual antenatal care on maternal and infant outcomes in Malawi.

BACKGROUND: Sub-Saharan Africa has the world's highest rates of maternal and perinatal mortality and accounts for two-thirds of new HIV infections and 25% of preterm births. Antenatal care, as the entry point into the health system for many women, offers an opportunity to provide life-saving monitoring, health promotion, and health system linkages. Change is urgently needed, because potential benefits of antenatal care are not realized when pregnant women experience long wait times and short visits with inconsistent provisioning of essential services and minimal health promotion, especially for HIV prevention. This study answers WHO's call for the rigorous study of group antenatal care as a transformative model that provides a positive pregnancy experience and improves outcomes. METHODS: Using a hybrid type 1 effectiveness-implementation design, we test the effectiveness of group antenatal care by comparing it to individual care across 6 clinics in Blantyre District, Malawi. Our first aim is to evaluate the effectiveness of group antenatal care through 6 months postpartum. We hypothesize that women in group care and their infants will have less morbidity and mortality and more positive HIV prevention outcomes. We will test hypotheses using multi-level hierarchical models using data from repeated surveys (four time points) and health records. Guided by the consolidated framework for implementation research, our second aim is to identify contextual factors related to clinic-level degree of implementation success. Analyses use within and across-case matrices. DISCUSSION: This high-impact study addresses three global health priorities, including maternal and infant mortality, HIV prevention, and improved quality of antenatal care. Results will provide rigorous evidence documenting the effectiveness and scalability of group antenatal care. If results are negative, governments will avoid spending on less effective care. If our study shows positive health impacts in Malawi, the results will provide strong evidence and valuable lessons learned for widespread scale-up in other low-resource settings. Positive maternal, neonatal, and HIV-related outcomes will save lives, impact the quality of antenatal care, and influence health policy as governments make decisions about whether to adopt this innovative healthcare model. TRIAL REGISTRATION: ClinicalTrials.gov registration number NCT03673709. Registered on September 17, 2018.

Randomized controlled pilot of a group antenatal care model and the sociodemographic factors associated with pregnancy-related empowerment in sub-Saharan Africa.

BACKGROUND: The links between empowerment and a number of health-related outcomes in sub-Saharan Africa have been documented, but empowerment related to pregnancy is under-investigated. Antenatal care (ANC) is the entry point into the healthcare system for most women, so it is important to understand how ANC affects aspects of women's sense of control over their pregnancy. We compare pregnancy-related empowerment for women randomly assigned to the standard of care versus CenteringPregnancy-based group ANC (intervention) in two sub-Saharan countries, Malawi and Tanzania. METHODS: Pregnant women in Malawi (n = 112) and Tanzania (n = 110) were recruited into a pilot study and randomized to individual ANC or group ANC. Retention at late pregnancy was 81% in Malawi and 95% in Tanzania. In both countries, individual ANC, termed focused antenatal care (FANC), is the standard of care. FANC recommends four ANC visits plus a 6-week post-birth visit and is implemented following the country's standard of care. In group ANC, each contact included self- and midwife-assessments in group space and 90 minutes of interactive health promotion. The number of contacts was the same for both study conditions. We measured pregnancy-related empowerment in late pregnancy using the Pregnancy-Related Empowerment Scale (PRES). Independent samples t-tests and multiple linear regressions were employed to assess whether group ANC led to higher PRES scores than individual ANC and to investigate other sociodemographic factors related to pregnancy-related empowerment. RESULTS: In Malawi, women in group ANC had higher PRES scores than those in individual ANC. Type of care was a significant predictor of PRES and explained 67% of the variation. This was not so in Tanzania; PRES scores were similar for both types of care. Predictive models including sociodemographic variables showed religion as a potential moderator of treatment effect in Tanzania. Muslim women in group ANC had a higher mean PRES score than those in individual ANC; a difference not observed among Christian women. CONCLUSIONS: Group ANC empowers pregnant women in some contexts. More research is needed to identify the ways that models of ANC can affect pregnancy-related empowerment in addition to perinatal outcomes globally.

Experiential Training Workshops for Group Antenatal Care in Malawi.

The positive effects of the CenteringPregnancy group antenatal care (ANC) model on perinatal outcomes in the United States has led to its adaptation and implementation in many low- and middle-income countries. Facilitative discussions are a core component of this group ANC model. Facilitator training lays a critical foundation for delivery of this paradigm-shifting model as practitioners learn to adapt their approach to health education from didactive to facilitative. However, there is little rigorous research focused on best practices for training group health care facilitators and none that is guided by a theoretical framework. Kolb's experiential learning theory offers a theoretical framework to guide the development of training workshops that allow trainees to experience, reflect on, and practice the facilitation skills needed to deliver this evidence-based intervention. This article describes an experiential learning-based training workshop that was implemented as part of an ongoing effectiveness-implementation trial of a Centering-based group ANC model in Blantyre District, Malawi. We provide a blueprint for conducting group ANC facilitator trainings that, in addition to imparting knowledge, effectively builds confidence and buy-in to this paradigm-changing approach to ANC delivery. This blueprint can be adapted for use in designing and implementing group health care across settings in the United States and globally.

Meconium aspiration syndrome: Incidence and outcomes using discharge data.

BACKGROUND: Meconium aspiration syndrome (MAS) is a leading cause of morbidity and mortality among term, otherwise healthy newborns, yet population studies are rare. Definitions, outcomes and International Classification of Diseases (ICD) codes are heterogenous, complicating estimates of incidence, outcomes and risks. AIMS: To measure population incidence, risks and outcomes of MAS by ICD codes. STUDY DESIGN: Retrospective population study. SUBJECTS: Kids Inpatient Database (KID) 2012, a nationally representative weighted sample of newborn discharges in the United States. OUTCOME MEASURES: Incidence, demographic distribution, and comorbidity associated with MAS. RESULTS: In 2012 there were 9295 weighted discharges diagnosed MAS with symptoms (2.49/1000) and 4304 cases without symptoms (1.15/1000). Newborns with symptoms had nearly twice the length of stay (LOS) (6.68 vs 3.65 days, p 0.001) and nearly 3 times the total charges ($44,473 versus $15,461, p < 0.001) as those without symptoms. Incidence of death was over four times higher (7.7/1000 vs 1.7/1000, p < 0.001), persistent pulmonary hypertension 3 times higher (57.6/1000 vs 15.8/1000, p < 0.001), and hypoxic ischemic encephalopathy 5 times higher (6.2/1000 vs 1.2/1000, p < 0.001) among MAS cases with respiratory symptoms than MAS cases without respiratory symptoms. Odds ratio of MAS with symptoms was 1.54 (95% CI 1.39-1.73) for black newborns compared to whites. CONCLUSIONS: Discharge data are useful for providing population estimates of MAS incidence. Prior studies have used consolidated ICD codes for MAS (with and without respiratory symptoms), yet these represent very different disease severities. Combining MAS diagnoses with and without respiratory symptoms misrepresents incidence and disease severity, complicating comparisons of outcomes and prevention strategies.

Implementation challenges and outcomes of a randomized controlled pilot study of a group prenatal care model in Malawi and Tanzania.

OBJECTIVE: To identify implementation challenges associated with conducting a randomized controlled trial (RCT) of group prenatal care (PNC) and report outcomes of the pilot. METHODS: A multi-site randomized pilot was conducted in Malawi and Tanzania between July 31, 2014, and June 30, 2015. Women aged at least 16 years with a pregnancy of 20-24 weeks were randomly assigned using sealed envelopes (1:1) to individual or group PNC. Structured interviews were conducted at baseline, in the third trimester and 6-8 weeks after delivery. The primary outcomes were attendance at four PNC visits and attendance at the 6-week postnatal visit. RESULTS: The pilot showed that an RCT with individual randomization can be conducted in these two low-resource settings. Significantly more women in group PNC than in individual PNC completed at least four PNC visits (96/102 [94.1%] vs 53/91 [58.2%]) and attended the postnatal visit (76/102 [74.5%] vs 45/90 [50.0%]; both P<0.001). CONCLUSION: Group PNC was feasible and associated with an increase in healthcare utilization and improved outcomes in Malawi and Tanzania. Lessons learned should be considered when designing large RCTs to determine efficacy. ClinicalTrials.gov: NCT02999334.

Centering pregnancy: a model for pregnant adolescents.

Recent exploration of the experiences of pregnant and parenting adolescents has uncovered the need to address the unique developmental, social, and cultural aspects of adolescent pregnancy. Many adolescents, especially those from urban areas, live in communities with limited opportunities, poverty, violence, and a lack of support. Programs that help young women discover their inner strength, create environments for empowerment, and build community may help adolescents to achieve goals and parent successfully. Centering Pregnancy is a model of group prenatal care that provides for the assessment, education, and support of pregnant women and may be particularly useful in adolescent populations. The model is described and the ways adolescents may benefit from Centering Pregnancy's unique design is discussed.

Redesigning prenatal care through CenteringPregnancy.

CenteringPregnancy is a model of group prenatal care that provides more than 20 hours of contact time between the childbearing care provider and a cohort of pregnant women with similar due dates. During this time, each woman has the opportunity to build community with other pregnant women, learn self-care skills, get assurance about the progression of her pregnancy, and gain knowledge about pregnancy, birth, and parenting. Ten essential elements have been defined, which contribute to the success of this model of prenatal care delivery. These elements correspond with the Institute of Medicine's 2001 challenge to improve the quality of health care in the United States. Foundational perspectives provide potential explanations for the model's growing influence and success. Implications for clinical practice and further research to link it with perinatal health outcomes are suggested.